Oral Steroid Treatment for Chronic Rhinosinusitis

Withdrawn before enrolling

Conditions studied: Chronic Rhinosinusitis

In brief

Despite the common use of oral steroids in the management of chronic rhinosinusitis (CRS), the natural history and efficacy of this treatment modality has not been fully elucidated. Specifically, patients who have undergone prior ESS and have recalcitrant CRS, the natural history of endoscopic improvement and quality of life (QoL) outcomes, following an oral steroid taper, is poorly defined. The purpose of this non-randomized single-arm clinical trial is to evaluate the effectiveness of an oral steroid taper in improving endoscopic grading, QoL, and olfactory function as well as defining the duration of improvement, in patients with recalcitrant CRS with prior endoscopic sinus surgery (ESS).

Key facts

Study ID

NCT01255683

Run by

Oregon Health and Science University

People needed

0

Starts

2010-12-01

Expected to finish

2011-11-01

Last updated by the study team

2015-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult ( > 18 years of age)
• CRS defined by 2007 Adult Sinusitis Guidelines.12
• Subject must be able to complete QoL questionnaires written in English
• Previous sinus surgery including unilateral or bilateral total ethmoidectomy
• Minimum nasal blockage score on SinoNasal Outcomes Test-22 (SNOT-22) > 3
• Severe sinonasal inflammation where the next treatment option is a 12- day oral prednisone taper
• Obstruction of the ethmoid sinus region or middle meatus eligible for revision endoscopic sinus surgery
• Lund-Kennedy endoscopy score > 4
• Elects 12-day tapering dose of oral steroids (Prednisone) as a next treatment option

You may not qualify if…

• Unable to complete questionnaires or clinical testing or cooperate with study evaluations in English
• Contra-indication to oral steroids
• Endoscopic sinus surgery < 3 months of presentation
• Completed course of oral corticosteroids within the previous 3 month period
• Subjects presenting with unilateral chronic rhinosinusitis
• Pregnancy or possibility to become pregnant during the study

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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